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U.S. Department of Health and Human Services


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Rulemaking History for OTC Expectorant Drug Products

Final Monograph (21 CFR part 341):
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use

OTC Expectorant Drug Products found on this page:

Expectorant Drug Products: Original Active Ingredients and Labeling
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 9/9/1976 41FR38312
    Reopening of Administrative Record [PDF] 3/21/1980 45FR18400
    Reopening of Administrative Record [PDF] 9/26/1980 45FR63874
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 7/9/1982 47FR30002
    Extension of Comment Period [PDF] 8/27/1982 47FR37934
Final Rule Date FR Citation
Final Monograph [PDF] 2/28/1989 54FR8494
    Correction [PDF] 3/22/1989 54FR11866
    Technical Amendment: Replaces "sputum" with "mucus" in indication [PDF] 6/30/1992 57FR29176
Final Rule: Classifies ipecac as nonmonograph [PDF] 9/14/1992 57FR41857
    Correction [PDF] 10/6/1992 57FR46067

Expectorant Drug Products: Combination Products
Proposed Rule Date FR Citation
Proposed Rule: Miscellaneous combinations [PDF] 8/12/1988 53FR30522
    Clarification: Includes promethazine HCl combinations [PDF] 11/14/1988 53FR45774
Notice: Prohibits OTC marketing of promethazine HCl combinations [PDF] 9/5/1989 54FR36762
Reopening of Administrative Record: Promethazine HCl combinations [PDF] 11/28/1989 54FR48914
   Correction [PDF] 1/4/1990 55FR310
   Extension of Comment Period [PDF] 1/24/1990 55FR2387
Proposed Rule: Bronchodilator, expectorant, and nasal decongestant combinations nonmonograph [PDF] 7/13/2005 70FR40232

Expectorant Drug Products: Pediatric Use
Proposed Rule Date FR Citation
Notice: Advisory Committee Meeting [PDF] 8/16/2007 72FR46091
Amendment of Notice: Advisory Committee Meeting [PDF] 10/1/2007 72FR55784
Notice of Public Hearing: Request for comments [PDF] 8/25/2008 73FR50033
Notice of Public Hearing: Correction [PDF] 9/2/2008 73FR51309